Phase II assessment of talabostat and cisplatin in second-line stage IV melanoma.
Phase II assessment of talabostat and cisplatin in second-line stage IV melanoma.
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DOI：
10.1186/1471-2407-9-263
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发表时间：
2009-07-30
期刊：
影响因子：
3.8
通讯作者：
Nemunaitis J
中科院分区：
文献类型：
--
作者：
Eager RM;Cunningham CC;Senzer NN;Stephenson J Jr;Anthony SP;O'Day SJ;Frenette G;Pavlick AC;Jones B;Uprichard M;Nemunaitis J
转移性黑色素瘤是一种无法治愈的疾病，平均生存期不到一年。塔拉司他是一种新型的二肽基肽酶抑制剂，具有免疫刺激特性。本项II期、开放标签、单组研究旨在评价75-100 mg/m2顺铂联合300-400 mcg塔拉司他bid治疗6个21天周期的安全性和疗效。主要终点为总体缓解。完全缓解率、总体客观缓解持续时间、无进展生存期（PFS）和总生存期为次要终点。在意向治疗人群的74例患者（8.1%）中记录了6例客观部分缓解。其中5例缓解涉及40例可评价患者（12.5%）。31%的患者报告了Talabostat和顺铂联合治疗的SAE。在意向治疗人群中观察到可接受的耐受性，在12.5%的可评价患者中观察到抗肿瘤活性，这不大于顺铂单药治疗的历史预期。
Metastatic melanoma is an incurable disease with an average survival of less than one year. Talabostat is a novel dipeptidyl peptidase inhibitor with immunostimulatory properties. This phase II, open label, single arm study was conducted to evaluate the safety and efficacy of 75–100 mg/m2 cisplatin combined with 300–400 mcg talabostat bid for 6, 21-day cycles. The primary endpoint was overall response. The rate of complete responses, duration of overall objective response, progression-free survival (PFS), and overall survival were the secondary endpoints. Six objective partial responses were recorded in the 74 patients (8.1%) in the intention-to-treat population. Five of these responses involved the 40 evaluable patients (12.5%). Thirty-one percent of patients reported SAEs to the combination of talabostat and cisplatin. Acceptable tolerability was observed in the intention-to-treat population and antitumor activity was observed in 12.5% of evaluable patients, which is not greater than historical expectation with cisplatin alone.
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